Brii Biosciences Limited, a leading biotechnology company, announced today that the National Medical Products Administration's Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designations for two investigational treatments targeting hepatitis B virus (HBV).

The first designation is for BRII-877 (tobevibart), a monoclonal antibody developed in collaboration with Vir Biotechnology (Vir). Supported by Phase 1 and 2 studies, which included over 350 individuals with HBV, BRII-877 has shown promising results in reducing HBsAg levels, indicating its potential as a crucial component of treatment for chronic HBV and hepatitis D virus (HDV) infections.

The second designation is for BRII-835 (elebsiran), a small interfering ribonucleic acid (siRNA) also developed in partnership with Vir. Clinical studies involving more than 570 HBV patients have demonstrated BRII-835's favorable safety profile and its direct antiviral activity against HBV and HDV.

Brii Bio, expressed confidence in the company's scientific approach, emphasizing the significance of these designations in their quest for a functional cure for HBV. With Breakthrough Therapy Designations for three therapeutic modalities, Brii Bio is well-positioned to address the diverse HBV patient populations, including those with HDV co-infections.

The company intends to build on this momentum by initiating multiple combination studies in 2024, in collaboration with Vir, to further optimize treatment regimens. These efforts are aimed at informing the company's registration strategy and ultimately bringing the most effective therapies to HBV patients.

HBV infection is a major global health threat, affecting over 254 million individuals worldwide, with China alone harboring 87 million cases. Furthermore, hepatitis D, which relies on HBV for replication, poses additional challenges, leading to more severe liver disease progression and increased mortality rates.

BRII-877 (tobevibart) and BRII-835 (elebsiran) represent innovative approaches in the pursuit of a functional cure for HBV, offering hope for millions of affected individuals worldwide.

 

Source: prnewswire.com

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